ASSESSMENT OF HUMAN FETUSES UNDERGOING ACUTE PAIN: VALIDATION OF THE FETAL-7 SCALE.

Improvements in fetal ultrasound have allowed for the diagnosis and treatment of fetal diseases in the uterus, often though surgery. However, little attention has been drawn to the assessment of fetal pain. To address this gap, a fetal pain scoring system, known as the Fetal-7 scale, was developed. The present study is a full validation of the Fetal-7 scale. The validation involved two steps: i. four fetuses with indication of surgery were evaluated in three conditions perioperatively: acute pain, rest, and under loud sound stimulation. Facial expressions were assessed by 30 raters using screenshots from 4D high-definition ultrasound films; ii., assessment of sensitivity and specificity of the Fetal-7 scale in 54 healthy fetuses and two fetuses undergoing acute pain after preoperative anesthetic intramuscular injection. There was high internal consistency with Cronbach's alpha (α) of 0.99. Intra-rater reliability of the Fetal-7 scale (test-retest) calculated by intraclass correlation coefficient (ICC) was 0.95, and inter-rater reliability was 0.99. The scale accurately differentiated between healthy fetuses at rest and those experiencing acute pain (sensitivity of 100% and specificity of 94.4%). The Fetal-7 scale is a valid tool for assessing acute pain-related behavior in third trimester fetuses and may be of value in guiding analgesic procedures efficacy in these patients. Further research is warranted to explore the presence of post-operative pain in fetuses and its effects afterbirth. PERSPECTIVE: Recordings with three-dimension ultrasound of human fetuses undergoing pre-operative anesthetic injections revealed complex facial expressions during acute pain, similar to those collected in newborns. This study presented the validation process and cut-off value of the Fetal-7 scale, paving the way for the study of pain before birth in humans.

[Simple, recurrent, and complicated urinary tract infections].

Urinary tract infection is a colonisation of the urinary tract with uropathogenic bacteria, leading to an inflammatory response. The increasing antimicrobial resistance presents major challenges for both the individual and our society. The goal is to reduce antimicrobial resistance and pave the way for a new era in the management of recurrent urinary tract infections. This review describes the definitions of urinary tract infection (simple, recurrent, and complicated) as well as examination and treatment recommendations. The future and most common non-antibiotic alternatives are discussed.

Cervical lesion proportion measure using a digital gridded imaging technique to assess cervical pathology in women with genital schistosomiasis.

Female genital schistosomiasis (FGS) is characterized by a pattern of lesions which manifest at the cervix and the vagina, such as homogeneous and grainy sandy patches, rubbery papules in addition to neovascularization. A tool for quantification of the lesions is needed to improve FGS research and control programs. Hitherto, no tools are available to quantify clinical pathology at the cervix in a standardized and reproducible manner. This study aimed to develop and validate a cervical lesion proportion (CLP) measure for quantification of cervical pathology in FGS. A digital imaging technique was applied in which a grid containing 424 identical squares was positioned on high resolution digital images from the cervix of 70 women with FGS. CLP was measured for each image by observers counting the total number of squares containing at least one type of FGS associated lesion. For assessment of inter- and intra-observer reliability, three different observers measured CLP independently. In addition, a rubbery papule count (RPC) was determined in a similar manner. The intraclass correlation coefficient was 0.94 (excellent) for the CLP inter-rater reliability and 0.90 (good) for intra-rater reliability and the coefficients for the RPC were 0.88 and 0.80 (good), respectively. The CLP facilitated a reliable and reproducible quantification of FGS associated lesions of the cervix. In the future, grading of cervical pathology by CLP may provide insight into the natural course of schistosome egg-induced pathology of the cervix and may have a role in assessing praziquantel treatment efficacy against FGS. Trial Registration: ClinicalTrials.gov, trial number NCT04115072; trial URL https://clinicaltrials.gov/ct2/show/NCT04115072?term=Female+genital+schistosomiasis+AND+Madagascar&draw=2&rank=1.

Validity and reliability of two Danish versions of the ICIQ-UI SF.

INTRODUCTION AND HYPOTHESIS: We aimed to assess the validity and reliability of two Danish versions of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) in a female population. We hypothesized that the questionnaires had good predictive validity, internal consistency, patient-physician agreement, construct validity, test-retest reliability, and sensitivity to change. METHODS: To test the predictive validity, we compared the ICIQ-UI SF to urodynamics (n = 153). The same answers were used for testing the internal consistency. The patient-physician agreement was assessed by comparing the self-administered questionnaire with a physician's evaluation based on telephone interviews (n = 60). To test the construct validity, we calculated the proportion of scores ≥ 1 in questionnaires completed by women defining themselves as "not suffering from involuntary urination" (n = 69). Test-retest reliability was assessed by comparing questionnaires completed twice with an interval of 2 weeks (n = 186). Sensitivity to change was evaluated by analyzing answers before and after treatment for women treated surgically for stress urinary incontinence (n = 755) and with botulinum type A toxin for overactive bladder (n = 63). RESULTS: Predictive validity: 26.6-27.6% agreement. Internal consistency: Cronbach's alpha: 0.7-0.8. Patient-physician agreement: 53.9-92.9% agreement. Some interview participants misunderstood the word "leak." Construct validity: 19% and 23% had a total score ≥ 1. Test-retest reliability: 77.0-95.7% agreement. Sensitivity to change: Significantly lower score after treatment. CONCLUSION: The ICIQ-UI SF had excellent internal consistency, patient-physician agreement, test-retest reliability, and sensitivity to change. The ICIQ-UI SF had questionable predictive validity and construct validity compared to urodynamic testing. We recommend precaution in diagnostics or research based solely on the questionnaire.

Pre- and postmenopausal women have different core urinary microbiota.

Recent studies suggest that alterations in the female urinary microbiota is associated to development of bladder disease. However, the normal microbiota composition and variation in healthy women are poorly described. Moreover, the effects of hormonal changes on microbiota during menopause is not well understood. The aim of our study was to investigate the urinary microbiota in healthy pre- and postmenopausal women without urinary tract symptoms. Microbiota composition in catheterized urine samples was mapped using 16S rRNA gene sequencing. In total, 41 premenopausal and 42 postmenopausal women were initially included. Samples with first PCR amplification concentration below level of the negative control were excluded, resulting in 34 premenopausal and 20 postmenopausal women included in data analysis. Urine from postmenopausal women showed significantly higher alpha diversity compared to premenopausal women. Lactobacillus was the most abundant bacteria in both groups, however the relative abundance of Lactobacillus accounted for 77.8% in premenopausal versus 42.0% in postmenopausal women. In conclusion, urine from premenopausal mostly presented with Lactobacillus dominated urotypes, whereas urine from postmenopausal women presented a more diverse urinary microbiota with higher abundance of the genera Gardnerella and Prevotella. The clinical and pathophysiological implications of this difference remain to be elucidated.

The Prevalence and Clinical Implications of Rectal SARS-CoV-2 Shedding in Danish COVID-19 Patients and the General Population.

Background: SARS-CoV-2 has resulted in a global pandemic since its outbreak in Wuhan, 2019. Virus transmission primarily occurs through close contact, respiratory droplets, and aerosol particles. However, since SARS-CoV-2 has been detected in fecal and rectal samples from infected individuals, the fecal-oral route has been suggested as another potential route of transmission. This study aimed to investigate the prevalence and clinical implications of rectal SARS-CoV-2 shedding in Danish COVID-19 patients. Methods: Hospitalized and non-hospitalized adults and children who were recently tested with a pharyngeal COVID-19 test, were included in the study. A rectal swab was collected from all participants. Hospitalized adults and COVID-19 positive children were followed with both pharyngeal and rectal swabs until two consecutive negative results were obtained. RT-qPCR targeting the envelope gene was used to detect SARS-CoV-2 in the samples. Demographic, medical, and biochemical information was obtained through questionnaires and medical records. Results: Twenty-eight of 52 (53.8%) COVID-19 positive adults and children were positive for SARS-CoV-2 in rectal swabs. Seven of the rectal positive participants were followed for more than 6 days. Two of these (28.6%) continued to test positive in their rectal swabs for up to 29 days after the pharyngeal swabs had turned negative. Hospitalized rectal positive and rectal negative adults were comparable regarding demographic, medical, and biochemical information. Furthermore, no difference was observed in the severity of the disease among the two groups. Conclusions: We provided evidence of rectal SARS-CoV-2 shedding in Danish COVID-19 patients. The clinical importance of rectal SARS-CoV-2 shedding appears to be minimal.

Voided Urinary Microbiota Is Stable Over Time but Impacted by Post Void Storage.

Background: New sensitive techniques have revealed a thriving bacterial community in the human urinary tract, challenging the perception that urine in healthy humans is sterile. While the functional role of this urinary microbiota is unknown, dysbiosis has been linked to urgency urinary incontinence and risk of urinary tract infections. When comparing studies, it is crucial to account for possible confounders introduced due to methodological differences. Here we investigated whether collection and storage conditions had any impact on the urinary microbial composition. Results: For comparison of different storage conditions, midstream urine was collected from five healthy adult female donors and analyzed by 16S rRNA gene sequencing. Samples stored at -80 and -20°C, but not 4°C, were found to be comparable to freshly handled voided urine. Using the same methods, the daily or day-to-day variation in urinary microbiota was investigated in 19 healthy donors, including four women, five men, five girls, and five boys. Apart from two male adult donors, none of the tested conditions gave rise to significant differences in alpha and beta diversities between individuals. Conclusion: The composition of voided urinary microbiota was found to be effectively maintained by freezing, but not storage at 4°C. In addition, we did not observe any intrapersonal daily or day-to-day variations in microbiota composition in women, girls or boys. Together our study supports present methodologies that can be used in future studies investigating the urinary microbiota.

Translation and validation of the International Consultation on Incontinence Questionnaire Vaginal Symptoms (ICIQ-VS): the Danish version.

INTRODUCTION: In the clinical evaluation of women with pelvic organ prolapse (POP), it is important to evaluate both objective and subjective presentations. The objective evaluation is done by gynecological examination, but the subjective presentation is more complex. The International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS) is an important tool for subjective evaluation, and a Danish version was developed. MATERIALS AND METHODS: The English version was translated into Danish in accordance with guidelines. Eight women underwent a semistructured interview showing no misunderstandings. Women with and without prolapse completed the questionnaire and underwent a Pelvic Organ Prolapse Quantification (POP-Q) examination. Three weeks later a retest was done. Women undergoing prolapse surgery completed the questionnaire 3 months postoperatively. RESULTS: Ninety-four women with and 98 without prolapse were included; 52 underwent surgery. Retest response rate was 88-95%. Mean time between test and retest was 24.5 and 92.2 days, respectively. Missing data ranged between 0 and 1%. Test-retest reliability was good to excellent (ICC 0.61-0.88) and internal consistency was acceptable (Cronbach's alpha 0.79-0.84). The questionnaire was excellent when distinguishing between women with and without prolapse (p < 0.001). Criterion validity (correlation between POP-Q stage and the questionnaire) was perfect (p < 0.001). Sensitivity to change was excellent for vaginal symptom score and quality of life (p < 0.001) but not for sexual matters (p = 0.059). CONCLUSIONS: The Danish version of ICIQ-VS was successfully translated and can be a valuable tool for prolapse research and daily evaluation of patients.